Proportion of participants whose least susceptible Pseudomonas aeruginosa (PA) isolate has a ≥ 4-fold increase in aztreonam minimum inhibitory concentration over 1 year and is above the parenteral breakpoint (> 8 μg/mL) [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]

This proportion will be compared annually over 5 years.

Original Primary Outcome Measures ICMJE (submitted: June 16, 2011)

Changes in susceptibility among Pseudomonas aeruginosa (PA) isolates to aztreonam [ Time Frame: 5 years ] [ Designated as safety issue: No ]

To determine whether there are any changes in susceptibility to aztreonam among Pseudomonas aeruginosa (PA) isolates from subjects with cystic fibrosis (CF) in the United States over the five year period after introduction of Cayston® (aztreonam for inhalation solution).

Annual number of Cayston treatment courses per participant and the total number of Cayston treatment courses at the end of each year in participants that used Cayston [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ICMJE (submitted: June 16, 2011)

Determine whether changes in clinical outcomes are associated with changes in susceptibility of PA isolates to aztreonam. [ Time Frame: 5 years ] [ Designated as safety issue: No ]

The secondary objective is to determine whether any changes in susceptibility are associated with changes in clinical outcomes, including changes in lung function, number and duration of hospitalizations, and body mass index (BMI).

Current Other Outcome Measures ICMJE

Not Provided

Original Other Outcome Measures ICMJE

Not Provided

Descriptive Information

Brief Title ICMJE

Registry to Monitor the Susceptibility to Aztreonam of Pseudomonas Aeruginosa Isolates From Cystic Fibrosis Patients

Official Title ICMJE

A Prospective, 5-year Registry Study to Monitor the Susceptibility to Aztreonam of Pseudomonas Aeruginosa (PA) Isolates From Patients With Cystic Fibrosis in the United States [AIR-CF5]

Brief Summary

This is a prospective, longitudinal, 5-year study that will enroll participants from the existing Cystic Fibrosis Foundation (CFF) patient registry. Each enrolled participant will provide samples for microbiological evaluation, obtained upon enrollment and then once per year thereafter for 5 years.

Detailed Description

Not Provided

Study Type ICMJE

Observational

Study Design ICMJE

Time Perspective: Prospective

Target Follow-Up Duration

Not Provided

Biospecimen

Retention: Samples Without DNA

Description:

Pseudomonas aeruginosa isolates from sputum or throat swab specimens

Sampling Method

Non-Probability Sample

Study Population

A representative cross-section of individuals with mild (FEV1 75% to ≤ 90% predicted), moderate (FEV1 40% to 74% predicted), or severe (FEV1 <40% predicted) lung disease and a history of ≥ 2 lower respiratory tract cultures positive for PA (at any time) will be enrolled. This will include approximately 100 individuals with pre-study exposure to Cayston (defined as having received at least one prior 28-day course of Cayston at any time before enrolling into the study). Enrollment will be monitored and potentially modified to ensure that adequate numbers of participants in each disease severity category are included. At the Investigator's discretion, participants enrolled in this study can be allowed to participate in clinical trials with other investigational therapies as appropriate.

Condition ICMJE

Cystic Fibrosis

Intervention ICMJE

Not Provided

Study Group/Cohort (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Abnormal nasal potential difference (NPD) AND accompanying clinical characteristics consistent with CF. For subjects who lack documentation of either a positive sweat chloride test or an abnormal NPD, and who have only one well-characterized genetic mutation of the CFTR gene, the diagnosis of CF is determined by the Investigator.

Subject must be able to provide written informed consent/assent prior to any study related procedure; parent/guardian must be able to give written informed consent as necessary prior to any study related procedure.

Key Exclusion Criteria:

Subjects who meet the following exclusion criterion are not to be enrolled in this study.

• Any serious active medical or psychiatric illness that, in the opinion of the Investigator, would interfere with subject assessment.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Gender

Both

Ages

6 Years and older (Child, Adult, Senior)

Accepts Healthy Volunteers

No

Contacts ICMJE

Contact information is only displayed when the study is recruiting subjects